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Completed

NCT Number: NCT01492829

A Community-health Worker Delivered HIV/STI Prevention Intervention for Internally Displaced Women in Leogane, Haiti

The investigators will develop, deliver and evaluate a solar powered tablet-based individual and group focused HIV/STI prevention intervention with internally displaced women in Leogane, Haiti. Internally displaced women will be trained as community health workers to deliver the HIV/STI prevention intervention to other internally displaced women.

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Key information

Conditions

Risk Reduction Behavior Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Interpersonal Relations Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

NEGES

Léogâne, Haiti

About this study

We will develop and field test a multi-component intervention that includes (1) solar-powered tablets with brief video-based educational messages and (2) 6 weekly peer-group sessions. The tablet will be programmed to analyze the data and to indicate incorrect HIV knowledge responses so the community health worker can immediately provide correct responses. This intervention involves 6 weekly women's health meetings that will cover a variety of issues pertinent to women's sexual health: HIV/AIDS, sexually transmitted infections, interpersonal relationships, communication and decision making, mental health and coping, creating social change.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 and over
  • capable of providing informed consent
  • internally displaced (living in tent or camp)
  • female

Exclusion criteria

  • male
  • under 18 years old
  • not able to provide informed consent

Treatment and study plan

individual and group-based, community health worker delivered

Behavioral

Pre-test will be individual, tablet-based; participants will receive correct information for incorrect HIV/STI knowledge responses and will watch a brief HIV/STI educational video. This will be followed by participants attending 6 weeks of group educational sessions focused on: HIV, STI, interpersonal relationships, communication and decision-making, mental health and coping, creating social change

Primary outcomes

  1. HIV Knowledge

    Time frame: 8 weeks

    Brief HIV Knowledge Questionnaire (Carey & Schroder, 2002)

Secondary outcomes

  1. Sexually Transmitted Infection Knowledge

    Time frame: 8 weeks

    Measured using Sexually Transmitted Disease Knowledge Questionnaire (Jaworski & Carey, 2007)

  2. Condom use

    Time frame: 8 weeks

    Measured using a self-report of frequency of condom use with regular, casual and paid sex sexual partners

  3. Substance use

    Time frame: 8 weeks

    Measured using self-reported frequency of drug/alcohol use

  4. Depression

    Time frame: 8 weeks

    Measured using Patient Health Questionnaire 2 (PHQ-2)

  5. Social support

    Time frame: 8 weeks

    Measured using Multi-dimensional scale of perceived social support (Zimet et al., 1988)

  6. resilient coping

    Time frame: 8 weeks

    Measured using Brief Resilient Coping Scale (Sinclair & Wallston, 2004)

  7. Relationship Control

    Time frame: 8 weeks

    Sexual Relationship Power Scale (Pulerwitz, Gortmaker & DeJong, 2000)

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • Adelphi University
  • NEGES Foundation, Leogane, Haiti

Registry information

Official study title

Development and Evaluation of a Community Health Worker Delivered HIV/STI Prevention Intervention for Women Living in Internally Displaced Persons Camps in Leogane, Haiti

Acronym: FASY

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2011
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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